FDA says pills can cause ‘sleep-driving’

It’s a more complicated version of sleepwalking, but behind
the wheel: getting up in the middle of the night and going for a drive — with
no memory of doing so.

The Food and Drug Administration wouldn’t say exactly how
many cases of sleep-driving it had linked to insomnia drugs, but neurology
chief Dr. Russell Katz said the agency uncovered more than a dozen reports —
and is worried that more are going uncounted.

Given the millions of prescriptions for insomnia drugs, Katz
called the problem rare, and said he was unaware of any deaths. But because
sleep-driving is so dangerous — and there are precautions that patients can
take — the FDA ordered a series of strict new steps Wednesday.

First, the makers of 13 sleep drugs must put warnings on
their labels about two rare but serious side effects:

1. Sleep-driving, along with other less dangerous
“complex sleep-related behaviors” — like making phone calls, fixing
and eating food, and having sex while still asleep.

2. Life-threatening allergic reactions, as well as severe
facial swelling, both of which can occur either the first time the pills are
taken or anytime thereafter.

Next, doctors this week will begin getting letters notifying
them of the new warnings.

Later this year, all prescription sleeping pills will begin
coming with special brochures called “Medication Guides” that spell
out the risks for patients in easy-to-understand language.

Sleep-driving made headlines last May when Kennedy, D-R.I.,
crashed his car into a security barrier outside the U.S. Capitol after taking
Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a
sedative. Kennedy has said he had no memory of the event. He pleaded guilty to
driving under the influence of prescription drugs, and was sentenced to
court-ordered drug treatment and a year’s probation.

Ambien isn’t the only insomnia drug that can cause
sleep-driving — any of the class known as “sedative-hypnotics” can,
FDA’s Katz stressed Wednesday.

To lower the risk of a sleep-driving episode, he advised
patients to never take any prescription insomnia drug along with alcohol or any
other sedating drug. Also, don’t take higher-than-recommended doses of the
pills.

“We really want people to know these things can occur,
and these sleep behaviors can be perhaps to a large extent mitigated by
behaviors the patients can control,” he said.

Some of the insomnia drugs may be riskier than others, so
FDA also recommended that manufacturers conduct clinical trials to figure that
out.

Fewer than one in 1,000 patients in studies of Ambien
reported somnambulism — a scientific term that includes the sleep behaviors
flagged by the FDA — said Lisa Kennedy, a spokeswoman for manufacturer
Sanofi-Aventis SA, who is not related to the congressman. The side effect has
remained similarly rare since widespread sales began, she said.

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